Study of Zifibancimig in Participants With Neovascular Age-Related Macular Degeneration

Last updated: March 26, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

1/2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Port Delivery Platform

Ranibizumab

Zifibancimig

Clinical Study ID

NCT04567303
BP41670
  • Ages > 50
  • All Genders

Study Summary

This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the Port Delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD)

Eligibility Criteria

Inclusion

Part 1, Part 2 and Part 3 Inclusion Criteria:

  • Willing to allow AH collection.

Part 1 and Part 2 Ocular Inclusion Criteria for Study Eye:

  • Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD).

  • Anti-vascular endothelial growth factor (VEGF) or anti-VEGF/Angiopoietin-2 (Ang-2) IVT treatment-naïve, or pre-treated with anti-VEGF or anti-VEGF/Ang-2 no less than two months prior to Day 1.

  • Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) images.

  • Decreased BCVA attributable primarily to nAMD, with BCVA letter score of 78 to 34 letters (inclusive) on ETDRS-like charts at screening. In case both eyes of a participant are eligible, the eye with the lower BCVA score should become the study eye.

Part 3 Ocular Inclusion Criteria for Study Eye:

  • CNV exclusively due to AMD.

  • Diagnosis of nAMD within 36-months prior to the screening visit.

  • Previous treatment with at least one IVT anti-VEGF or anti-VEGF/Ang-2 administrations IVT for nAMD. The last IVT administration must have occurred at least 21 days prior to the screening visit.

  • Demonstrated response to prior IVT anti-VEGF or anti-VEGF/Ang-2 treatment since diagnosis.

  • Availability of historical VA data prior to the first anti-VEGF or anti-VEGF/Ang-2 treatment for nAMD.

  • Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading.

  • Decreased BCVA attributable primarily to nAMD with letter score of 78 to 34 letters (inclusive) or better on ETDRS-like charts.

Ocular Exclusion Criteria for Study Eye:

  • History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period.

  • Cataract surgery without complications within three months preceding the screening visit or planned during the study period.

  • Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also an exclusion criterion, unless it occurred as a result of yttrium-aluminum garnet laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.

  • Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation.

  • Prior treatment with IVT corticosteroids or implant (e.g., triamcinolone, ozurdex, iluvien).

  • Subretinal hemorrhage >50% of the total lesion area and/or involving the fovea.

  • Subfoveal fibrosis or subfoveal atrophy.

  • Retinal pigment epithelial tear involving the macula.

  • History of vitreous hemorrhage, rhegmatogenous retinal detachment, glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery, and corneal transplant.

  • History of rhegmatogenous retinal tears or peripheral retinal breaks within three months prior to the screening visit.

  • Actual or history of myopia >-8 diopters.

  • Uncontrolled ocular hypertension or glaucoma (defined as intraocular pressure (IOP) >25 millimeters of mercury (mm Hg) or a cup to disc ration >0.8, despite treatment with antiglaucoma medication) and any such condition the Investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study.

  • Concurrent intraocular conditions (e.g., cataract, diabetic retinopathy, epiretinal membrane with traction, macular hole) that, in the opinion of the Investigator, could either:

  • Require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or

  • Likely contribute to loss of BCVA over the study period if allowed to progress untreated; or

  • Preclude any visual improvement due to substantial structural damage.

  • Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PD implant.

  • Prior treatment with any medication for geographic atrophy during the last 3 months prior to screening.

  • Prior treatment with any anti-VEGF-C or anti-VEGF-D inhibitors.

Exclusion Criteria for Fellow Eye

  • BCVA letter score using ETDRS charts of < 34 letters.

  • Treatment with IVT anti-VEGF or anti-VEGF/Ang-2 agents within one week prior to Day 1 (concurrent treatment with SUSVIMO^TM in the fellow eye is not exclusionary).

Exclusion Criteria for Either Eye

  • CNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis or central serous chorioretinopathy.

  • Prior participation in a clinical trial involving anti-VEGF drugs within six months prior to the screening visit, other than ranibizumab, aflibercept, or faricimab including approved biosimilars.

  • Active intraocular inflammation (grade trace or above), infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.

  • History of uveitis, including history of any intraocular inflammation following intravitreal therapy.

  • Prior treatment with brolucizumab.

  • Prior gene therapy for nAMD

Study Design

Total Participants: 251
Treatment Group(s): 3
Primary Treatment: Port Delivery Platform
Phase: 1/2
Study Start date:
October 28, 2020
Estimated Completion Date:
December 29, 2027

Connect with a study center

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • The Retina Partners

    Encino, California 91436
    United States

    Active - Recruiting

  • Retinal Consultants Med Group

    Sacramento, California 95841
    United States

    Active - Recruiting

  • West Coast Retina Medical Group

    San Francisco, California 94109
    United States

    Active - Recruiting

  • Orange County Retina Med Group

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Southwest Retina Consultants

    Durango, Colorado 81303
    United States

    Active - Recruiting

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Retina Vitreous Assoc of FL

    Saint Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • Retina Associates of Florida, LLC

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Retina Associates

    Lenexa, Kansas 66215
    United States

    Site Not Available

  • Maine Eye Center

    Portland, Maine 04101
    United States

    Active - Recruiting

  • Johns Hopkins Med

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • The Retina Care Center

    Baltimore, Maryland 21209
    United States

    Active - Recruiting

  • Retina Group of Washington

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Cumberland Valley Retina Associates

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Foundation for Vision Research

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Associated Retinal Consultants

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • VitreoRetinal Surgery, PLLC.

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Midwest Vision Research Foundation

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • The Retina Institute

    Saint Louis, Missouri 63128
    United States

    Active - Recruiting

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Site Not Available

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Mid Atlantic Retina - Wills Eye Hospital

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • Long Is. Vitreoretinal Consult

    Hauppauge, New York 11788
    United States

    Active - Recruiting

  • Retina Vit Surgeons/Central NY

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Graystone Eye

    Hickory, North Carolina 28602
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • OSU Eye Physicians & Surgeons

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Charleston Neuroscience Inst

    Ladson, South Carolina 39456
    United States

    Active - Recruiting

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Southeastern Retina Associates

    Knoxville, Tennessee 37923
    United States

    Active - Recruiting

  • Tennessee Retina PC.

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Retina Res Institute of Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Austin Clinical Research LLC

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina & Vitreous of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Retina Consultants of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • Brown Retina Institute

    San Antonio, Texas 78251-4551
    United States

    Active - Recruiting

  • Retina Center of Texas

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas 77384-4167
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Wagner Kapoor Institute

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Active - Recruiting

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